Efficacy of Dapagliflozin in Diabetes Associated Peripheral Neuropathy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic peripheral neuropathy(DPN) is a length dependent axonal neuropathy that affects at least 50% of patients with diabetes mellitus. DPN is often asymptomatic during the early stages of diabetes ,however, once symptoms and overt deficits have developed, it cannot be reversed. Early diagnosis of neuropathy is important because early diagnosis and timely intervention might prevent the development and progression of diabetic neuropathy.Though glycemic control has been shown to prevent the progression of diabetic microvascular complications including diabetic peripheral neuropathy in Type I DM, such strict glycemic control has not shown to improve diabetic peripheral neuropathy in Type 2 DM. There are only few animal studies conducted so far which have shown that the use of SGLT2 inhibitors prevents the progression of diabetic peripheral neuropathy.Thus the investigators postulate that the use of SGLT2 inhibitor in patients with Type 2 Diabetes Mellitus might be beneficial in the prevention of progression of diabetic peripheral neuropathy as well as reverse it.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

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Type 2 Diabetes Mellitus < 5 years duration

Age >18yrs

Presence of neuropathy at baseline (accessed by Michigan Neuropathy Screening Instrument score >7 )

estimated Glomerular Filtration rate (eGFR) > 45ml/min/m2

HBA1c < 9

Exclusion Criteria:

Untreated Hypothyroidism

Patients currently on SGLT2 inhibitors History of Leprosy

Patients with history of and current foot ulcers

Presence of Peripheral Vascular disease(ABI <0.9)

B12(<200 pg/ml)/ Folate (<4.6 ng/ml)

History of alcohol abuse (>2 standard drink per day for males and >1 standard drink for females)

Factors affecting corneal nerves( severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months)

Negative consent

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